Sold as Dienestrol. Every FDA application for this active ingredient: 1 branded and 3 generic.
As of Nov 13, 2026, FDA lists 4 applications for Dienestrol (sold as Dienestrol), first approved Jan 9, 1947, with 4 new uses approved and 0 published complete response letters.
| Jan 9, 1947 | DienestrolNDA 6110 | Ortho Mcneil Pharm | 18 | Discontinued |
| Nov 4, 1975 | EstraguardANDA 84436 | Solvay | 0 | Discontinued |
| — | DvANDA 83517 | Sanofi Aventis US | 0 | Discontinued |
| — | DvANDA 83518 | Sanofi Aventis US | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Sanofi Aventis US